MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BLADE MOD 2.75IN; E-Z CLEAN BLADE MODIFIED 2.75 INCH

Model Number	0012AM
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).User facility number: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No lot or batch number was provided therefore a device history could not be done.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during a tonsillectomy on (b)(6) 2021.The procedure was uncomplicated.At the end of the procedure, it was noted that the patient had burn injuries to both the right and left sides of the oral commissure.A literature review of oral burns during electrocautery tonsillectomy indicated that inadvertent oral cavity burns could occur from electrocautery devices.It is possible that the electrocautery electrode tip had become dislodged/loosened.This would leave an uninsulated portion of the electrode tip exposed which could potentially come in contact with the patient's oral tissue allowing arching of the electrical current and causing the burns.

• Brand Name: E-Z CLEAN BLADE MOD 2.75IN
• Common Device Name: E-Z CLEAN BLADE MODIFIED 2.75 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 12041148
• Report Number: 1721194-2021-00049
• Device Sequence Number: 4421528
• Product Code: GEI
• UDI-Device Identifier: 10614559100103
• UDI-Public: 10614559100103
• Combination Product (Y/N): N
• PMA/510(K) Number: K081791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0012AM
• Device Catalogue Number: 0012AM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1